Clinical trials: Pseudomonas Infections
Bacterial Disease Carrier, Cystic Fibrosis
A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa
This is a phase 1b/2 study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF).
- Trial name
- NCT05453578
- Testing
- WRAIR-PAM-CF1
- Where
- 19 sites in United States
- Volunteers
- 73 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pneumonia, Hematologic Malignancy
Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation
The goal of this clinical trial is to learn whether the antibiotic ceftolozane-tazobactam works to treat serious Pseudomonas aeruginosa infections in people with blood cancers or who received a stem cell transplant.
- Conditions
- Pneumonia, Hematologic Malignancy, Pseudomonas Aeruginosa Infection, Bacteremia
- Trial name
- NCT04673175
- Testing
- Ceftolozane / Tazobactam Injection
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Weill Medical College of Cornell University
Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa
Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic…
- Conditions
- Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection
- Trial name
- Tailwind (NCT05616221)
- Testing
- AP-PA02
- Where
- 23 sites in United States
- Volunteers
- 48 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Cystic Fibrosis, Pseudomonas Aeruginosa
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered…
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection
- Trial name
- SWARM-Pa (NCT04596319)
- Testing
- AP-PA02
- Where
- 20 sites in United States
- Volunteers
- 29 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Cystic Fibrosis
CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)
This is a Phase 2 study with primary objective of looking whether YPT-01 phage therapy reduces sputum bacterial load in cystic fibrosis subjects with Pseudomonas aeruginosa.
- Trial name
- NCT04684641
- Testing
- Standard Dose YPT-01
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Yale University
Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa…
- Trial name
- ALPINE 2 (NCT03219164)
- Testing
- AZLI
- Where
- 53 sites in United States, Austria and 10 more
- Volunteers
- 149 people
- Sponsor
- Gilead Sciences
Pseudomonas Aeruginosa Pneumonia
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.
- Trial name
- NCT03027609
- Testing
- AR-105
- Where
- 111 sites in United States, Australia and 15 more
- Volunteers
- 158 people
- Sponsor
- Aridis Pharmaceuticals, Inc.
Cystic Fibrosis
Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis
Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs.
- Trial name
- PIPE-CF (NCT01694069)
- Testing
- Piperacillin-tazobactam combination product
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- West Virginia University
Tracheostomy Infection
The Use of Inhaled Aztreonam in Children With a Tracheostomy Tube and Pseudomonas
This is a prospective, case-control clinical trial using inhaled Aztreonam (AZLI) in pediatric patients with a tracheostomy tube colonized with Pseudomonas aeruginosa.
- Trial name
- A-PACT (NCT03158116)
- Testing
- Inhaled Aztreonam
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- UCSF Benioff Children's Hospital Oakland
Pseudomonas Aeruginosa, Cystic Fibrosis
Open Label Extension to Bridging Study CTBM100C2303
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas…
- Trial name
- NCT00982930
- Testing
- Tobramycin inhalation powder
- Where
- 2 sites in Estonia, Russia
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Infections, Pseudomonas Aeruginosa
Second Open Label Extension to Bridging Study CTBM100C2303
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were…
- Trial name
- NCT01069705
- Testing
- Tobramycin inhalation powder
- Where
- 17 sites in Bulgaria, Estonia and 5 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Pseudomonas Aeruginosa
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.
- Trial name
- EVADE (NCT02696902)
- Testing
- MEDI3902
- Where
- 78 sites in United States, Austria and 12 more
- Volunteers
- 188 people
- Sponsor
- MedImmune LLC
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients
There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation, Pseudomonas Aeruginosa Infection
- Trial name
- NCT02421120
- Testing
- Ceftolozane/Tazobactam
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Joseph L. Kuti, PharmD
Pseudomonas Aeruginosa Infection
Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections.
- Trial name
- NCT01315678
- Testing
- Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
- Where
- 62 sites in Austria, Belgium and 16 more
- Volunteers
- 302 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis
OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis
The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of…
- Trial name
- OPTIMIZE (NCT02054156)
- Testing
- azithromycin, Tobramycin solution for inhalation
- Where
- 45 sites in United States
- Volunteers
- 221 people
- Sponsor
- Bonnie Ramsey
Bronchiectasis
Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas…
- Trial name
- NCT00775138
- Testing
- 280 mg Arikayce™, 560 mg Arikayce™
- Where
- 18 sites in United States, Bulgaria and 7 more
- Volunteers
- 64 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis
A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)
The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary function as measured by a 5% or greater relative improvement in forced expiratory volume in one second (FEV1) from baseline to Day 28.
- Trial name
- NCT02354859
- Testing
- Gallium nitrate, Normal Saline
- Where
- 23 sites in United States
- Volunteers
- 119 people
- Sponsor
- University of Washington
Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis
Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa
The purpose of the study was to evaluate lung clearance index (LCI) by a standardized procedure in a well characterized study setting and to assess feasibility of LCI as a more sensitive method than forced expiratory volume at 1…
- Trial name
- ELIXIR (NCT02248922)
- Testing
- TIS or TIP
- Where
- 6 sites in Germany
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis, Pneumonia
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation.
- Conditions
- Cystic Fibrosis, Pneumonia, Pseudomonas Aeruginosa Infection
- Trial name
- NCT01429259
- Testing
- meropenem
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- Joseph Kuti
Bacterial Pneumonia
Clinical Trials to Reduce the Risk of Antimicrobial Resistance
The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical…
- Trial name
- NCT01570192
- Testing
- IV meropenem, I.V. Meropenem, Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 43 people
- Sponsor
- University of Florida